LDN for Fibromyalgia!
Low Dose Naltrexone has a long history of helping all sorts of people with all sorts of health problems.
Research on LDN for Fibromyalgia
Low-Dose Naltrexone Reduces the Symptoms of Fibromyalgia
by Dr. Tom GilhoolyThe 2nd European LDN conference in Glasgow this year saw the first presentation of a remarkable study into LDN for the treatment of fibromyalgia by Dr Jarred Younger of Stanford University. This is the sort of top quality research that we have been crying out for, and perhaps even more remarkable than the results of the study was Dr Younger's clarity on how LDN works. The vacuum that has existed in LDN research has been filled by lots of myths and legends such as timing of administration and dosage of the drug. Dr Younger explained that LDN is a "racemic mix" of mirror image right and left handed molecules. This is common in chemistry, and most drugs consist of such a natural mix. It is usual for only one of the sides to be biologically active, but in the case of LDN both sides are active. The right handed molecule blocks the opiate receptors, which confer the action which the drug is licensed for i.e. blocking the action of heroin and other illicit opiates.
The more interesting part regards the left handed molecule, which acts on the Toll-like 4 receptors on the surface of immune cells and acts as an immune modulator. Dr Younger studied the effect on microglial cells, a type of immune cells important to the neurological system which become active when the immune system is activated. These cells are important in fibromyalgia, but also in MS , Parkinson's Disease and several other neurological conditions. The left handed (levo) naltrexone binds to these receptors and reduces the inflammatory chemicals that are pouring out of these cells. This idea makes great sense and fits very well with our findings in the clinic. If this is the mode of action, it fits with the hypothesis of Dr Agrawal and others, and the timing of dose is irrelevant. This is a big discovery, but even Dr Ian Zagon from Penn State who is a big advocate of the opiate hypothesis, states that timing is not an important factor. This would suggest that the opiate-blocking effect of LDN is actually the limiting factor on dose and we should aim to get the highest dose possible that the patient can tolerate, to produce the greatest effect on the immune system. It also puts paid to the idea that LDN is an "immune booster" which should not be used with other immune modulators. In fact it is likely that LDN will be synergistic with these drugs.
As if this was not enough for one month, along comes the much anticipated double-blind study on Crohn's Disease by Prof Jill Smith and Ian Zagon from Penn State. This shows a remarkable 83% improvement in the LDN group, with almost half going into remission. Not surprisingly given the participation of Dr Zagon, they ascribe the improvements to increased opiate expression, but the alternative action could be just as viable. In Crohn's disease and other inflammatory bowel diseases including Coeliac's disease, there is an increase in Toll Like 4 Receptor numbers on the bowel mucosa. This could explain the rapid and dramatic response to LDN of many patients with these conditions.
Fibromyalgia Symptoms are reduced by low-dose naltrexone: A pilot study.
Pain Medicine (2009)
Jarred W. Younger and Sean C. Mackey
What is fibromyalgia?
People with fibromyalgia complain of chronic pain in the muscles of their body. They are also often profoundly fatigued, and have difficulty sleeping well. Headaches, stomach problems, and a number of other symptoms are frequently reported. Millions of people in the United States meet the criteria for fibromyalgia, and the condition seems to affect more women than men. The disorder can be debilitating, as the pain and fatigue prevent the individual from carrying out their normal activities. There are three FDA-approved medications for fibromyalgia, but not all individuals respond well to those treatments.
What is low-dose naltrexone?
We tested a medication called low-dose naltrexone (LDN). Naltrexone is a medication that has been used for many years to treat opioid addiction. When given at a smaller dose (usually 4.5mg), the drug may help to reduce pain associated with inflammatory and autoimmune conditions, such as multiple sclerosis and Crohn's disease. LDN is not FDA-approved for the treatment of pain, and is still experimental. LDN capsules are typically taken once per day.
What was the study?
We ran a small study to see if individuals with fibromyalgia would receive benefit from taking LDN. Ten women were enrolled in the study -- all of whom met the criteria for fibromyalgia. The participants were given a handheld computer to record their pain, fatigue, and other symptoms on a daily basis. They filled out the daily report for two weeks before receiving capsules. Then they received capsules to take once daily. The participants received placebo for two weeks, and then LDN for 8 weeks. The study was single-blind, so participants did not know when they were receiving placebo or LDN. Finally, participants stopped taking the capsules and continued to fill out the daily reports for two more weeks.
Did the drug work?
We were very encouraged by the results. In six out of ten participants, LDN was significantly better than placebo at reducing fibromyalgia symptoms. LDN reduced daily pain, the highest level of pain, fatigue, and stress. Other symptoms, such as sleep problems, gastrointestinal complaints, and headaches, also seemed to be helped.
Pain Medicine (2009). Overall, self-reported, daily fibromyalgia symptoms (scale 0 – 100, with 100 being most severe symptoms). Time periods are: baseline, placebo, LDN, and washout. The data are separated into drug responders (solid line, 6 people) and drug nonresponders (broken line, 4 people). Drug responders are individuals who had at least a 30% greater reduction of symptoms during LDN versus placebo.
What were the side-effects?
We did not observe any serious side-effects during the course of the study. The most commonly reported side-effect (reported by 2 participants) was more vivid dreams. All of the participants who started the study finished the entire 14-week protocol.
